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Location: Indianapolis, IndianaWarning Letter Date: September 9, 2025FDA Department Issuing Warning: Center for Drug Evaluation and Research (CDER)Type of Warning: False & Misleading Claims/Misbranded DrugsSubject of Violation: An Oprah Special: Shame, Blame, and the Weight Loss Revolution, regarding Zepbound (tirzepatide) and Mounjaro (tirzepatide)FDA Warning: In the program, which aired on television in 2024 and until recently was available continuously on the ABC website and through various streaming services, Eli Lilly promoted Mounjaro and Zepbound in a manner that failed to present the serious risks of these drug products in a truthful and nonmisleading manner, despite FDAs prior correspondence (advisory comments dated June 13, 2022 and June 21, 2022)
Most patients report minimal to mild discomfort with GLP-1 injections used for type 2 diabetes and weight management
The AGA and ACG provide evidence-based guidelines emphasizing treat-to-target strategies, with objective monitoring through endoscopy, cross-sectional imaging, and biomarkers (C-reactive protein, fecal calprotectin) to assess mucosal healing and optimize outcomes
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